A Systematic Review

Drug risks are often found after market approval. This article reviews prior literature on how the U.S. Food and Drug Administration (FDA) communicates risks to the general public and providers, and its impact on drug utilization, health outcomes, and health care services.

The authors searched for published manuscripts on MEDLINE (via PubMed) and Web of Science (Thomson Reuters) from January 1, 1990 through November 10, 2010. Forty-nine studies matched the eligibility criteria and were included in the analysis. The studies covered 16 drugs or therapeutic classes with one-third regarding antidepressants. For the study, the authors defined risk communication as “activities used to inform the public or health care providers of risk of a medical product.”

Key Findings:

Drug advisories and label changes often had strong, immediate impacts. However, some showed either a delay or no impact on health care utilization or health behavior.